title: RESEARCH (Recognized effect of Statin and ezetimibe therapy for achieving LDL-C Goal), a randomized, doctor-oriented, multicenter trial to compare the effects of higher-dose statin versus ezetimibe-plus-statin on the serum LDL-C concentration of Japanese type-2 diabetes patients design and rationale.
abstract: OBJECTIVE
  Hypercholesterolemia coexisting with diabetes still requires clinical intervention to manage the high risk of cardiovascular disease it poses. No second-step strategy is established, however, for cases where strong statins fail to bring cholesterol down to target levels. In this study we seek to demonstrate the superior effect of ezetimibe in combination with strong statins to reduce LDL-C in Japanese patients suffering from both T2DM and hyper LDL-cholesterolemia.
  
  
  METHODS
  T2DM outpatients (109 patients from 16 institutes) who failed to achieve the target LDL-C value were recruited and randomly assigned to two groups, a double-dose-statin group and ezetimibe-plus-statin group. Follow-ups were scheduled at 0, 12, 26, and 52 weeks. The primary endpoint was the percentage change in the level of LDL-C from baseline to 12 weeks.
  We could successfully create randomized (gender, age, LDL-C, HbA1c, etc.) two groups except for slight differences in apolipoprotein-B and sd-LDL.
  
  
  CONCLUSIONS
  RESEARCH is the first prospective, parallel-group, multicenter study comparing a double dose of strong statin with ezetimibe plus strong statin for T2DM patients. The RESEARCH study will provide reliable evidence with which to establish a clinical strategy for diabetics who fail to achieve the target LDL-C value.
authors.affiliation: Toho University Ohashi Medical center, Tokyo, Japan. teruo.shiba@med.toho-u.ac.jp.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Inazawa
authors.forename: Kentaro
authors.initials: K
authors.lastname: Sakamoto
authors.forename: Takahide
authors.initials: T
authors.lastname: Kohro
authors.forename: Raisuke
authors.initials: R
authors.lastname: Iijima
authors.forename: Toru
authors.initials: T
authors.lastname: Kitazawa
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Hirano
authors.forename: Mitsunobu
authors.initials: M
authors.lastname: Kawamura
authors.forename: Motoki
authors.initials: M
authors.lastname: Tagami
authors.forename: Akira
authors.initials: A
authors.lastname: Tanaka
authors.forename: Yasumichi
authors.initials: Y
authors.lastname: Mori
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Yamazaki
authors.forename: Teruo
authors.initials: T
authors.lastname: Shiba
mesh_terms: D000367:Age Factors; D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D001055:Apolipoproteins B / Q000097:blood; D001384:Azetidines / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000069438:Ezetimibe; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012737:Sex Factors; D019821:Simvastatin / Q000627:therapeutic use*
chemical_list: D000924:Anticholesteremic Agents; D001055:Apolipoproteins B; D001384:Azetidines; D008078:Cholesterol, LDL; D000069438:Ezetimibe; D006442:Glycated Hemoglobin; D019821:Simvastatin; C517652:hemoglobin A1c protein, human